FDA.reportPublic FDA data

GeneXpert Infinity-80 System

Primary DI
07332940004019
Brand
GeneXpert Infinity-80 System
Company
CEPHEID
Model
INFINITY 80-40
Catalog number
900-0498
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940004019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940004019073329400040197332940004019

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888383222techsupport@cepheid.com

Regulatory Flags#

DUNS number
956711444
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332940009489XpertGXGI-10GXGI-102026-01-30
07332940009694GeneXpert®GX-IV R22026-01-19
07332940009700GeneXpert® XpressGX-IV Xpress2026-01-19
07332940009687GeneXpert®GeneXpert XVI (GX-XVI)2025-08-15
07332940009366GeneXpert®GXHCV-10 GXHCV-10 2024-07-22
07332940008161GeneXpert®XPRSGBS-10XPRSGBS-102024-02-16
07332940008581GeneXpert®XPRS-COV2-10XPRS-COV2-102024-01-22
07332940009243GeneXpert® XpressGX-IV XpressGX-IV Xpress2023-10-20
07332940008604GeneXpert®XPRS4PLEX-10XPRS4PLEX-102023-09-25
07332940007652Xpert®GXGBSLBXCGXGBSLBXC-102022-07-29
07332940007669Xpert®GXGBSLBXCGXGBSLBXC-1202022-07-29
07332940007195GeneXpert®GXIV-HUB900-08282022-05-12
07332940006457Xpert®SWAB/F-100SWAB/F-1002022-05-03
07332940007683GeneXpert®GX-II R2GX-II R22022-05-03
07332940007690GeneXpert®GX-IV R2GX-IV R22022-05-03
07332940007706GeneXpert®GX-XVI R2GX-XVI R22022-05-03
07332940007713GeneXpert®GX-INFINITY 48SGX-INFINITY 48S2022-05-03
07332940007720GeneXpert®GX-INFINITY 80GX-INFINITY 802022-05-03
07332940007072Xpert®XPRSMVP-10XPRSMVP-102022-04-13
07332940008345Xpert®SWAB/G-50-USSWAB/G-50-US2022-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
07332940009700GeneXpert® XpressCEPHEIDOOI2026-01-19
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904452797Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
06955792700857Q-Vera Pico 6X qPCR InstrumentSansure Biotech Inc.OOI2025-09-18
04053228041849QIAstat-Dx® RiseQIAGEN GmbHOOI2025-09-05
07332940009687GeneXpert®CEPHEIDOOI2025-08-15
00811877012153ID NOW InstrumentAlere Scarborough, Inc.OOI2025-08-01
10190302019859Diomni™ Software, Version 4.2.0LIFE TECHNOLOGIES HOLDINGS PTE. LTD.OOI2025-05-02
06973843220802careSTART™ Q1 AmplifierHangzhou Bioer Technology Co., Ltd.OOI2025-02-11
06955792700864Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2024-10-29
04053228047582QIAstat-Dx Analyzer 2.0QIAGEN GmbHOOI2024-09-18
08809537078412Exicycler™ V5 96Bioneer CorporationOOI2024-09-09
08809537078429Exicycler™ V5 96 FastBioneer CorporationOOI2024-09-09
08809537078436Exicycler™ V5 384Bioneer CorporationOOI2024-09-09
08809537078443Exicycler™ V5 384 FastBioneer CorporationOOI2024-09-09
04719889100102CHROMA ATECHROMA ATE INC.OOI2024-07-26
30014613340089SavannaDIAGNOSTIC HYBRIDS, INC.OOI2024-07-19
30014613339304SavannaDIAGNOSTIC HYBRIDS, INC.OOI2024-04-30
10190302019514Diomni™ Software, Version 4.1.0LIFE TECHNOLOGIES HOLDINGS PTE. LTD.OOI2024-04-26
00382904431594BD Pre-warm HeaterBECTON, DICKINSON AND COMPANYOOI2024-03-19
04719890680013QuarkBio®QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)OOI2023-12-12
04719890680020QuarkBio®QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)OOI2023-12-12
06974689625158TARGETINGONETargetingOne Technology (Beijing) CorporationOOI2023-10-20
06974689625165TARGETINGONETargetingOne Technology (Beijing) CorporationOOI2023-10-20